Method of determining a chemotherapeutic regimen based on ERCC1 and TS expression
AssigneeResponse Genetics, Inc.
InventorKathleen D. Danenberg
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Abstract
The present invention relates to prognostic methods which are useful in medicine, particularly cancer chemotherapy. The object of the invention to provide a method for assessing TS and/or ERCC1 expression levels in fixed or fixed and paraffin embedded tissues and prognosticate the probable resistance of a patient's tumor to treatment with 5-FU and oxaliplatin-based therapies by examination of the amount of TS and/or ERCC1 mRNA in a patient's tumor cells and comparing it to a predetermined threshold expression level for those genes. More specifically, the invention provides to oligonucleotide primer pairs ERCC1 and TS and methods comprising their use for detecting levels of ERCC1 and TS mRNA, respectively.
Claims9
A method for determining a chemotherapeutic regimen comprising 5-fluorouracil, oxaliplatin, or combination thereof for treating a tumor in a patient comprising:
- (a) isolating mRNA from a fixed tumor tissue sample;
- (b) subjecting the mRNA to reverse transcriptase-polymerase chain reaction (RT-PCR) amplification using a pair of oligonucleotide primers capable of amplifying a region of the Excision Repair Cross-Complementing (ERCC1) gene, and a pair of oligonucleotide primers capable of amplifying a region of the Thymidylate Synthase (TS) gene, to obtain an ERCC1 and a TS amplified sample;
- (c) determining the amount of TS and ERCC1 mRNA in the amplified sample;
- (d) comparing the amount of TS and ERCC1 mRNA from step (c) to an amount of mRNA of an internal control gene;
- and
- (e) determining a chemotherapeutic regime comprising 5-flurouracil, oxaliplatin, or combination thereof based on the amount of TS and/or ERCC1 mRNA in the amplified sample and the threshold level for TS and/or ERCC1 gene expression.
Dependencies are inferred from the claim text.